| CTRI Number |
CTRI/2025/07/091478 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study on Utkleshana, Doshahara and Shamana Basti in Gridhrasi Sciatica Syndrome |
|
Scientific Title of Study
|
To evaluate the effect of utkleshana doshahara and shaman basti in the management of gridhrasi sciatica syndrome |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nancy Garg |
| Designation |
PG Scholar |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP |
| Address |
PG Department of Panchakarma Room no 111 Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP
Bhopal MADHYA PRADESH 462007 India |
| Phone |
9406504919 |
| Fax |
|
| Email |
nancygarg.garg021@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Preeti Chaturvedi |
| Designation |
Reader |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP |
| Address |
PG Department of Panchakarma room no 111 Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP
Bhopal MADHYA PRADESH 462007 India |
| Phone |
7999013557 |
| Fax |
|
| Email |
preetichaturvedi227@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Preeti Chaturvedi |
| Designation |
Reader |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP |
| Address |
PG Department of Panchakarma room no 111 Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP
Bhopal MADHYA PRADESH 462007 India |
| Phone |
7999013557 |
| Fax |
|
| Email |
preetichaturvedi227@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of panchkarma Pt Khushilal Sharma Governemnt Autonomous Ayurveda College and Institute Bhopal MP 462007 |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Panchakarma Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP 462007 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nancy Garg |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal(MP) |
PG Department of Panchakarma room no 111 Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP Bhopal MADHYA PRADESH |
09406504919
nancygarg.garg021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Pt Khushilal Sharma Government Ayurveda College and Institute Bhopal (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shephalika patra kashyam , Reference: Bhaisajyaratnavali jwara rogadhikar chapter 5, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 18 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shephalika Patra Kashayam, Reference: Bhaisajyaratnavali jwara rogadhikar chapter 5, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 18 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Shushrut Samhita Chikitsa Sthana 38, Procedure details: 20 patients of this group will be administered with utkleshana doshahara and shaman basti for 9 days.) (1) Medicine Name: Utkleshana Doshahara and Shaman basti, Reference: SHUSHRUTA SAMHITA chikitsa sthana 38, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 640(ml), Frequency: od, Duration: 9 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex between the age group 21 to 60 years
Patient fit for basti karma
Patient having a classical features of Gridhrasi
Patient having classical sign and symptomss of Sciatica according to modern text i.e. tenderness along the course of sciatica nerve ,positive SLR test etc
Patient willing to participate in the study by signing written consent |
|
| ExclusionCriteria |
| Details |
Post surgical cases of spine
Patient having Ca/ Tumor of spine etc
Patient suffering from chronic debilitating disease like TB,DM or any other chronic disease
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of the study we would be able to demonstrate the effect of Trividh basti (UDSB) in the management of Gridhrasi
( Sciatica Syndrome) |
12 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
From this study It is expected that at the end of the study we would be able to demonstrate the effectiveness of Utkleshana Doshahara and Shaman basti in the management of Gridhrasi Sciatica Syndrome. |